Activity Precautions
Medtronic ITB TherapySM (Intrathecal Baclofen Therapy) may be able to help you perform activities that weren’t previously possible. In general, you should be able to resume your normal daily activities. However, be sure to consult your doctor or nurse before undertaking any particularly strenuous activities. The information below will help you understand more about activities to avoid or special precautions you may need to take once you have an implanted infusion pump.
Activities Requiring Excessive Twisting or Stretching
Avoid activities that put undue stress on the implanted components of your infusion system. Activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching can damage the components or cause the catheter to dislodge. This can require surgery to repair or replace the components. The catheter could also become kinked or blocked, preventing drug delivery and resulting in a loss of or change in therapy that can lead to serious injury or death.
Activities Involving Exposure to High Altitudes
Before engaging in activities at high altitudes (such as airline flights, skiing or hiking in the mountains), discuss the effects of low pressure with your doctor. Patients who live or travel at high altitudes are exposed to lower air pressures. With continued exposure to lower pressure, the flow rate of the pump may increase and then stay at the higher rate. If your doctor determines that such an increase in flow rate might pose an undue risk to you, your doctor can adjust your infusion prescription to offset this higher flow rate.
In rare cases, exposure to the lower pressures can cause the flow rate of the SynchroMed II pump to exceed the programmed flow rate by more than 14.5% while the patient is exposed to the lower pressure. The infusion prescription in SynchroMed pumps can be changed for patients who will be exposed to lower pressures.
Activities Involving Exposure to High Temperatures
If the temperature of a hot tub, steam room, sauna, or tanning bed is greater than 39˚C (102˚F), you should not use it. The flow rate of the pump will vary with body temperature. The flow rate increases as the temperature increases. If the increase is significant, the pump can deliver too much medication. This may lead to serious injury or death.
Activities Involving Exposure to High Pressure
Do not dive below 10 meters (33 feet) of water or enter hyperbaric chambers above 2.0 atmospheres absolute (ATA). Pressures below 10 meters (33 feet) of water (or above 2.0 ATA) could damage the pump, requiring surgery to replace the pump. To minimize damage to the pump when hyperbaric treatment is required, your doctor should fill the pump to capacity using the appropriate refill kit and maintain the current infusion prescription prior to exposure to hyperbaric conditions. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with your doctor. As pressure increases, pump flow decreases. Continuing to increase the pressure will eventually lead to serious injury or death.
Component Manipulation
Do not manipulate or rub the pump or catheter through the skin; this is sometimes called “Twiddler’s syndrome.” Manipulation can cause skin erosion, component damage, catheter disconnection, kinking, or dislodgement. Damage to the components of your infusion system can require surgery to repair or replace the components. Catheter disconnection and kinking can result in drug or spinal fluid leakage into tissue and tissue damage, or a loss of or change in therapy that can lead to serious injury or death. Manipulation may also cause the pump to flip over, making it impossible to refill the pump.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call
IMPORTANT SAFETY INFORMATION ON ITB THERAPY
Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure and death. It is very important that your doctor be called right away if you experience any of the above symptoms.
It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to understand the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; consult with your doctor.
People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be a candidate for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis you must first fail oral baclofen. If you have experienced a traumatic brain injury you must first wait 1 year after the injury to be considered for ITB Therapy. A screening test will help show if you will respond to the intrathecal baclofen. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small to hold the implantable pump.
The implanted pump and catheter are surgically placed beneath the skin. Surgical complications that you may experience include infection, meningitis, spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.
The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Pump failure may cause overdose or underdose of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia, seizures, loss of consciousness, and coma. Once the infusion system is implanted, device complications include catheter or pump moving within the body or eroding through the skin. The catheter could leak, tear, kink, or become disconnected, resulting in underdose or no baclofen infusion. Symptoms of underdose include increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early indications of baclofen withdrawal. The pump could stop because the battery has run out or because of component failure. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced or if there is a problem with the pump. Always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.
For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.
This therapy is not for everyone. Please contact your doctor. A prescription is required.
Lioresal® is a registered trademark of Medtronic, Inc.
USA Rx Only Rev 0911
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.
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